MMJ International Holdings Following FDA Guidance in Cannabis Drug Development Process

ACCESSWIRE11 May 2019, 03:43 GMT+10

ST. PETERSBURG, FL / ACCESSWIRE / May 10, 2019 / MMJ International Holdings, the premier medical cannabis research company, recently announced that the FDA has made an award for ''Orphan Drug Designation'' for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington's Disease. The drug, MMJ-002 is one of MMJ's lead drugs and the company is confident that it will bring much needed relief to patients suffering from the debilitating effects of Huntington's Disease.

Since 2015, MMJ has been advancing the science of medical marijuana federally legal through development of patient clinical trials and research. This latest award of Orphan Drug Designation is in keeping with MMJ's mission to do everything possible to improve the lives of patients.

This MMJ Orphan Drug award by the FDA means that MMJ has demonstrated its promise for the diagnosis and/or treatment of rare diseases or conditions. Orphan designation qualifies MMJ International Holdings for various development incentives provided by the Orphan Drug Award, including tax credits for qualified clinical testing.

As stated by MMJ's CEO, Duane Boise, ''MMJ's Orphan Drug award is another milestone that the company has meet as we continue to set industry standards. MMJ has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise''.

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Not generally recognized as safe and effective for these uses and, therefore, rendered 'new drugs' under Section 201(p) of the FDA Act that are barred from being introduced into interstate commerce without prior FDA approval (which is solely provided on the basis of scientific data and information demonstrating that drug is safe and effective);

Misbranded under Section 502(f)(1) of the FDA Act for failing to bear adequate 'intended use(s) directions' defined as 'directions under which a layperson can use a drug safely and for the {intended} purposes' or as 'prescription drugs' which 'can only be used safely at the direction, and under the supervision, of a licensed practitioner'; and

Intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without a licensed practitioner's supervision' and for which it is 'impossible to write adequate directions for.

MMJ International Holdings continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio and DEA regulatory manufacturing guidelines.